On November 5, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported recent business highlights and financial results for the third quarter ended September 30, 2026.

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"With our commercial team in place, we are prepared to execute on the anticipated launch of bezuclastinib in GIST," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "In parallel, our team is preparing for potential approvals in NonAdvanced and Advanced Systemic Mastocytosis and we expect to file INDs for our JAK2 and KRAS pipeline programs this quarter. Backed by a strong balance sheet and a world-class team, we are well positioned to continue our vision of creating best-in-class therapies for patients fighting rare, mutationally driven diseases."

Business Highlights

•
Plan to present multiple posters featuring bezuclastinib at the 68th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) being held December 12-15, 2026, in New Orleans. Featured results will highlight more detailed analyses from the SUMMIT trial of bezuclastinib’s effects on skin and neurocognitive symptoms, longer term pathobiology follow-up and an MS2D2 symptomatic comparison of symptom burden in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients before and after bezuclastinib treatment with that of the general population. Included in these presentations will be the first look at clinical results from the SUMMIT sub-study, investigating the patient benefit of switching from avapritinib to bezuclastinib.
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Announced the initiation of a single-arm, 40 patient extension cohort of the PEAK trial investigating the safety and efficacy of bezuclastinib in combination with sunitinib in first-line GIST patients. This cohort is designed to prospectively measure ORR and PFS in patients with either exon 9 or exon 11 primary mutations.
•
Announced the U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM).

Anticipated Upcoming Milestones

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Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026
•
Potential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026
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Potential FDA approval of bezuclastinib in AdvSM – PDUFA date of June 29, 2027
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Investigational New Drug (IND) applications to be submitted for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor, and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor in Q4 2026
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Complete dose escalation for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor
Upcoming Investor Conferences

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Guggenheim Healthcare Innovation Conference on November 10 at 7:30 am ET
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UBS Global Biopharma Conference on November 17 at 12:00 pm GMT (7:00 am ET)
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Jefferies Global Healthcare Conference on November 17 at 5:00 pm GMT (12:00 pm ET)
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Piper Sandler Healthcare Conference on December 1 at 11:00 am ET
The live webcasts can be accessed on the Investors & Media page of Cogent’s website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of each event and will be archived for up to 30 days.

Third Quarter 2026 Financial Results

Cash Position: As of September 30, 2026, cash, cash equivalents and marketable securities were $791.1 million, as compared to $792.3 million as of June 30, 2026. The company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into late 2028, well past all three pending PDUFA action dates for bezuclastinib.

R&D Expenses: Research and development expenses were $75.1 million for the third quarter of 2026 as compared to $69.0 million for the third quarter of 2025. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $7.5 million for the third quarter of 2026 compared to $5.4 million for the third quarter of 2025.

G&A Expenses: General and administrative expenses were $42.1 million for the third quarter of 2026 as compared to $14.4 million for the third quarter of 2025. The increase was primarily due to continued investments in commercial readiness, including personnel and infrastructure to support the potential launch of bezuclastinib, as well as overall organizational growth. G&A expenses include non-cash stock compensation expense of $9.4 million for the third quarter of 2026 compared to $5.2 million for the third quarter of 2025.

Net Loss: Net loss was $111.4 million for the third quarter of 2026 as compared to a net loss of $80.9 million for the same period of 2025.

(Press release, Cogent Biosciences, NOV 5, 2026, View Source [SID1234674302])

On November 5, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the third quarter and nine months ended September 30, 2026.

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"Our team delivered another strong quarter, reflecting consistent execution across our portfolio," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "TissueCypher was a key contributor to our top-line performance, delivering 47% year-over-year growth in test report volume compared to the third quarter of 2025. We generated $19.7 million in net cash provided by operating activities, reflecting our disciplined approach to expense management and operational efficiency while continuing to invest in strategic growth opportunities.

"DecisionDx-Melanoma continues to serve as the foundation of our dermatologic testing franchise, with 5% year-over-year growth in test report volume through the first nine months of 2026 compared to the same period in 2025. Alongside DecisionDx-Melanoma, AdvanceAD-Tx and DecisionDx-SCC broaden the clinical value of our dermatologic portfolio and position us to support our medium- and long-term growth opportunities, and combined, our dermatology commercial team delivered 15,168 test reports in the third quarter.

"Overall, our third-quarter results reflect the strength of our portfolio, consistent execution and continued progress toward our long-term growth objectives. I want to thank the entire Castle team for their dedication, hard work and unwavering commitment to improving patient care."

Third Quarter Ended Sep. 30, 2026, Financial and Operational Highlights
•Revenues were $102.9 million, compared to $83.0 million in the third quarter of 2025.

Core revenue drivers:
•Third quarter 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 22% over the third quarter of 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,177, compared to 10,459 in the third quarter of 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 15,574, compared to 10,609 in the third quarter of 2025.

Additional tests:
◦DecisionDx-SCC test reports delivered in the quarter were 3,882, compared to 4,186 in the third quarter of 2025.
◦MyPath Melanoma test reports delivered in the quarter were 798, compared to 1,151 in the third quarter of 2025.

◦DecisionDx-UM test reports delivered in the quarter were 422, compared to 436 in the third quarter of 2025.
◦AdvanceAD-Tx test reports delivered in the quarter were 1,109. The test was not offered during the third quarter of 2025.
◦Esopredict test reports delivered in the quarter were 469. The test was not offered during the third quarter of 2025.

•Gross margin was 75%, and Adjusted Gross Margin was 77%, compared to 75% and 77%, respectively, for the same periods in 2025.
•Net loss, which includes non-cash stock-based compensation expense of $11.2 million, was $4.1 million, compared to net loss of $0.5 million for the same period in 2025.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.13, compared to net loss per share and Adjusted Net Loss per Share, Basic and Diluted, of $0.02, for the same period in 2025.
•Adjusted EBITDA was $12.7 million, compared to $9.2 million for the same period in 2025.
•Net cash provided by operations was $19.7 million, compared to net cash provided by operations of $22.6 million for the same period in 2025.

Nine Months Ended Sep. 30, 2026, Financial and Operational Highlights
•Revenues were $290.1 million, compared to $257.2 million for the nine months ended September 30, 2025. Affecting comparison to 2025 includes the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.

Core revenue drivers:
•Nine months ended September 30, 2026, total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 29% over the nine months ended September 30, 2025.
◦DecisionDx-Melanoma test reports delivered in the nine months ended September 30, 2026, were 30,478, compared to 29,061 for the same period in 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the nine months ended September 30, 2026, were 42,307, compared to 27,211 for the same period in 2025.
Additional tests:
◦DecisionDx-SCC test reports delivered in the nine months ended September 30, 2026, were 11,595, compared to 13,323 for the same period in 2025.
◦MyPath Melanoma test reports delivered in the nine months ended September 30, 2026, were 2,832, compared to 3,243 for the same period in 2025.
◦DecisionDx-UM test reports delivered in the nine months ended September 30, 2026, were 1,396, compared to 1,374 for the same period in 2025.
◦AdvanceAD-Tx test reports delivered in the nine months ended September 30, 2026, were 2,548. The test was not offered during the nine months ended September 30, 2025.
◦Esopredict test reports delivered in the nine months ended September 30, 2026, were 986. The test was not offered during the nine months ended September 30, 2025.

•Gross margin for the nine months ended September 30, 2026, was 74%, and Adjusted Gross Margin was 77%, compared to 67% and 80%, respectively, for the same period in 2025.

•Net loss, which includes non-cash stock-based compensation expense of $32.6 million, was $20.7 million, compared to net loss of $21.8 million for the same period in 2025.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.69, compared to net loss per share and Adjusted Net Loss per Share, Basic and Diluted, of $0.76 and $0.06, respectively, for the same period in 2025.
•Adjusted EBITDA was $20.0 million, compared to $32.5 million for the same period in 2025.
•Net cash provided by operations was $12.8 million, compared to $37.4 million net cash provided by operations for the same period in 2025.
Cash, Cash Equivalents and Marketable Investment Securities
As of Sep. 30, 2026, the Company’s cash, cash equivalents and marketable investment securities totaled $277.7 million.
2026 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2026. The Company now anticipates generating between $385-395 million in total revenue in 2026, compared to the previously provided guidance of between $365-375 million. Further, the Company maintains its expectation to achieve positive Adjusted EBITDA for the fourth quarter 2026, the full year 2026 and the full year 2027.

Third Quarter 2026 Highlights

Dermatology – Skin Cancer
•In September, the Company presented new data on DecisionDx-Melanoma from the largest, prospective multi-center study of gene expression profiling (GEP) in cutaneous melanoma to date, involving 2,799 patients across 29 U.S. centers. This study, presented at the European Academy of Dermatology and Venereology (EADV) Congress 2026, supports the use of DecisionDx-Melanoma in sentinel lymph node biopsy (SLNB) and risk of recurrence decision-making management. Among 676 patients with low-risk i31-SLNB results who underwent SLNB had an observed SLN positivity of 4.4%, and 565 SLNB-eligible patients with low-risk results who did not undergo SLNB had five-year recurrence-free survival (RFS) of 99.6%. These findings support identifying low-risk patients who may safely forgo SLNB. A separate analysis of 687 patients with transected melanomas showed that patients with early-stage disease (stage I–IIA) and high-risk Class 2B results had recurrence risk similar to stage IIB disease, supporting closer surveillance when staging is uncertain. See the Company’s news release from September 30, 2026, for more information.
•The Company announced the publication of a multi-center study in the Journal of the American Academy of Dermatology (JAAD) validating the integrated DecisionDx-SCC test result (i40-GEP) for patients with high-risk cutaneous squamous cell carcinoma (SCC). DecisionDx-SCC analyzes 40 genes to provide results related to prognosis and response to adjuvant radiation therapy (ART) based on an individual patient’s tumor biology. The enhanced algorithm integrates the molecular data with five clinicopathologic risk factors (immunosuppression, tumor diameter, histological differentiation, perineural invasion and anatomic site) using optimized nested predictive models. This integrated approach provides a comprehensive assessment of metastatic risk, local recurrence risk and likelihood of benefit from ART. The study published in JAAD showed that the test results can shift or stratify patients across clinically actionable risk thresholds, supporting risk-aligned decisions regarding patient follow-up, surveillance imaging, multidisciplinary referral and ART. See the Company’s news release from September 9, 2026, for more information.

Dermatology – Atopic Dermatitis
•The Company announced the publication of a new study highlighting the challenges patients with atopic dermatitis (AD) experience in achieving their treatment goals and

strong patient interest in molecular testing to help guide systemic therapy selection. The findings support the clinical need for molecular guidance in AD care. Castle’s AdvanceAD-Tx test is designed to address this need by helping personalize systemic therapy decisions based on an individual patient’s underlying disease biology. This new paper complements an earlier prospective, multicenter clinical validation study in the Journal of the American Academy of Dermatology that demonstrated the ability of AdvanceAD-Tx to identify differences in systemic therapy class response in patients with moderate-to-severe AD. See the Company’s news release from September 24, 2026, for more information.

Gastroenterology
•The Company announced the publication of a study showing that its TissueCypher Barrett’s Esophagus test helped guide risk-aligned management decisions for patients with non-dysplastic Barrett’s esophagus (NDBE). In the study, clinicians changed their management recommendations 90% of the time after receiving TissueCypher results, including escalating management for all patients with intermediate- or high-risk results and de-escalating management for 84% of those with low-risk results. See the Company’s news release from September 28, 2026, for more information.
•The Company announced the publication of a new decision modeling study showing that the TissueCypher Barrett’s Esophagus test can help better align Barrett’s esophagus (BE) management with a patient’s individual risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). In the study, simulated use of TissueCypher significantly increased appropriate management aligned with known progression outcomes across patients with NDBE, indefinite for dysplasia (IND) and low-grade dysplasia (LGD). See the Company’s news release from September 15, 2026, for more information.
Pipeline Initiatives
•In September, SciBase, the Company’s collaboration partner developing the use of electrical impedance spectroscopy technology to predict relapses in atopic dermatitis announced that Castle placed an additional order for acceleration of the Company’s current, ongoing clinical study and preparations for a second clinical study under the collaboration. The order consisted of both the portable pen device and electrodes to a value of approximately $0.6 million. Deliveries began early in the fourth quarter 2026.

Corporate
•The Company announced the opening of its new laboratory and office facility in Scottsdale, Arizona. The 55,000-square-foot facility, located within the 260-acre Perimeter Center business park, expands Castle’s operational footprint in the Phoenix metropolitan area. This investment gives our teams additional space, infrastructure and capacity to support our work on behalf of patients and clinicians today as well as our anticipated growth in the future. See the Company’s news release from September 22, 2026, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Thursday, November 5, 2026, at 4:30 p.m. Eastern time to discuss its third quarter 2026 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until November 26, 2026.
There will be a brief Question & Answer session following management commentary.

(Press release, Castle Biosciences, NOV 5, 2026, View Source [SID1234674301])

On November 5, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU) reported financial results for the third quarter of 2026.

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Third quarter 2026 financial results
Licensing and other third-party revenue: Revenue from licensing and other third-party agreements was $1.6 million for the three months ended September 30, 2026, compared to $2.2 million for the same period in 2025.

R&D expenses: Research and development expenses were $21.3 million for the three months ended September 30, 2026, compared to $22.4 million for the same period in 2025.

G&A expenses: General and administrative expenses were $7.9 million for the three months ended September 30, 2026, compared to $9.2 million for the same period in 2025.

GAAP net loss and net loss per share, basic and diluted: Caribou reported a GAAP net loss of $26.6 million, or $0.25 per share, basic and diluted, for the three months ended September 30, 2026, compared to $27.5 million, or $0.30 per share, basic and diluted.

Cash, cash equivalents, and marketable securities: Caribou had $94.8 million in cash, cash equivalents, and marketable securities as of September 30, 2026, compared to $142.8 million as of December 31, 2025.
October 6, 2026 announcement
On October 6, 2026, Caribou announced that its Board of Directors had approved a restructuring of operations as the company conducts a process to explore strategic alternatives to maximize stockholder value, which may include, but are not limited to, a merger, acquisition, business combination, or other strategic transactions involving the company and/or its assets, including dissolution and liquidation.

Included in the restructuring is the planned discontinuation of Caribou’s clinical trials and further development activities for vispa-cel and CB-011, a substantial reduction in workforce, and other cost reduction measures. The Board took these actions in view of the current financing environment for allogeneic CAR-T cell therapies, which has made it increasingly challenging to secure the capital necessary to responsibly advance vispa-cel and CB-011.

Caribou has not set a timeline for the completion of the review of strategic alternatives, does not intend to provide further updates unless and until the Board has approved a course of action, the review process is concluded, or disclosure is otherwise determined to be appropriate or required.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. Vispa-cel is pivotal trial-ready, with FDA alignment already reached on the phase 3 clinical trial design. To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy to demonstrate safety, efficacy, and durability on par with autologous CAR-T cell therapies. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E-peptide fusion protein to blunt immune-mediated rejection. Clinical data from the CB-011 CaMMouflage phase 1 trial has demonstrated the potential for deep, durable responses in patients with r/r MM. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

(Press release, Caribou Biosciences, NOV 5, 2026, View Source [SID1234674300])

On November 5, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science, reported financial results for the third quarter ended September 30, 2026, as well as recent business highlights.

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"Throughout the year, we have continued to build evidence supporting cemsidomide’s potential as a backbone therapy across the multiple myeloma treatment landscape while advancing our clinical development plan to evaluate cemsidomide in late and earlier lines of therapy," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "Growing clinical and translational insights from our program as well as the broader class of cereblon-modulating protein degraders of IKZF1/3 continue to support the potential for these investigational treatments to enhance immune-based therapies, reinforcing our conviction in cemsidomide’s development strategy. Looking ahead, we remain focused on completing enrollment in our Phase 2 MOMENTUM trial and advancing the Phase 1b trial in combination with elranatamab. With data expected from these trials in 2027, we believe next year will be pivotal in establishing cemsidomide’s therapeutic profile and its potential to address the significant unmet need of patients with multiple myeloma across an evolving standard of care."

THIRD QUARTER 2026 UPDATES AND RECENT ACHIEVEMENTS

The Phase 1b trial evaluating cemsidomide in combination with elranatamab (ELREXFIO), a B-cell maturation antigen (BCMA) × CD3 bispecific antibody, in earlier lines of multiple myeloma (MM) treatment continues to advance. The Safety Data Review Committee determined that the 75 µg cemsidomide dose level was safe to proceed, and the trial has advanced to a dose escalation safety cohort at the 100 µg cemsidomide dose level and an expansion cohort at the 75 µg cemsidomide dose level. Data from all evaluated cohorts are expected in mid-2027.
C4T presented new biomarker data from its Phase 1 and Phase 1b clinical trials at the 23rd International Myeloma Society (IMS) Annual Meeting in September 2026. Immunomodulatory effects observed in the Phase 1 trial evaluating cemsidomide in combination with dexamethasone demonstrated robust T-cell activation, a key component of cemsidomide’s dual mechanism of action. In addition, early biomarker data from the first two patients enrolled in the Phase 1b trial evaluating cemsidomide in combination with elranatamab reinforced cemsidomide’s ability to drive T-cell activation and expansion as well as prevent T-cell exhaustion. These data continue to support cemsidomide’s potential as a combination partner for immune-based therapies in relapsed refractory multiple myeloma (RRMM).
A trial-in-progress poster featuring the Phase 1b design for the trial evaluating cemsidomide in combination with elranatamab in RRMM will be presented at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place from December 12 – 15, 2026, in New Orleans, Louisiana.
Title: A multicenter study to evaluate the safety and preliminary antimyeloma activity of different doses of cemsidomide in combination with elranatamab in subjects with RRMM
Date/Time: December 12, 2026 from 5:30 – 7:30 PM CT/ 6:30 – 8:30 PM ET
The Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone in late-line MM is on track to complete enrollment in the first quarter of 2027. The initial investigator-assessed overall response rate (ORR) data are expected in the second half of 2027.
An additional Phase 1b trial evaluating cemsidomide across two treatment arms in RRMM patients is on track to initiate in the first half of 2027. The trial will evaluate: 1) cemsidomide, dexamethasone, and daratumumab, a CD38-targeted antibody; and 2) cemsidomide, dexamethasone, and carfilzomib, a proteasome inhibitor. Both treatment arms will enroll patients who have received at least one prior line of therapy. The cemsidomide starting dose will be 75 µg.
At the 9th Annual Targeted Protein Degradation Summit that took place from October 26 – 29, 2026, C4T unveiled its novel DNA-encoded library (DEL) that leverages C4T’s large library of cereblon-binding ligands and screening capabilities. The addition of DEL to C4T’s TORPEDO platform creates a powerful hit-finding engine that enables the rapid development of targeted protein degraders.
UPCOMING MILESTONES

By year-end 2026: Deliver at least one development candidate to a collaboration partner and advance collaborations toward key milestones.
1Q 2027: Complete enrollment of the Phase 2 MOMENTUM trial.
1H 2027: Initiate an additional Phase 1b trial evaluating cemsidomide in combination with approved MM therapies.
Mid-2027: Present new data from all cohorts evaluated in the Phase 1b trial of cemsidomide in combination with elranatamab.
2H 2027: Present initial ORR data from the Phase 2 MOMENTUM trial.
UPCOMING NOVEMBER INVESTOR EVENTS

November 9, 2026 at 11:00 am ET: Management will participate in a fireside chat at the Guggenheim 3rd Annual Healthcare Innovation Conference taking place in Boston, MA from November 9 – November 11, 2026.
November 17, 2026, at 9:30 am GMT/4:30 am ET: Management will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference in London taking place in London, UK from November 16 – November 19, 2026.
THIRD QUARTER 2026 FINANCIAL RESULTS

Revenue: Total revenue for the third quarter of 2026 was $8.5 million, compared to $11.2 million for the third quarter of 2025. The decrease was primarily related to the conclusion of certain research activities in 2025 associated with the collaborations with Merck and Merck KGaA, Darmstadt Germany, offset by an increase in revenue recognized under the Roche Degrader-Antibody Conjugate collaboration agreement.

Research and Development (R&D) Expense: R&D expense for the third quarter of 2026 was $24.8 million, compared to $26.0 million for the third quarter of 2025. The decrease in R&D expense was primarily due to lower personnel costs from reduced stock-based compensation expense, offset by higher clinical expense associated with the advancement of its ongoing cemsidomide clinical trials.

General and Administrative (G&A) Expense: G&A expense for the third quarter of 2026 was $8.3 million compared to $8.9 million for the third quarter of 2025. The decrease in G&A expense was primarily due to lower personnel costs from reduced stock-based compensation expense.

Net Loss and Net Loss per Share: Net loss for the third quarter of 2026 was $21.8 million, compared to $32.2 million for the third quarter of 2025. Net loss per share for the third quarter of 2026 was $0.16, compared to $0.44 for the third quarter of 2025.

Cash Position and Financial Guidance: Cash, cash equivalents, and marketable securities as of September 30, 2026, were $274.7 million, compared to $300.4 million as of June 30, 2026, and $297.1 million as of December 31, 2025. The decrease in cash, cash equivalents, and marketable securities during the third quarter of 2026 was driven by cash used to fund operations and advance its programs. C4T expects that its current cash, cash equivalents and marketable securities will fund its operating plan to the end of 2028.

About Cemsidomide
Cemsidomide is an investigational oral cereblon-modulating protein degrader of IKZF1/3, transcription factors foundational to multiple myeloma biology. Data from the fully enrolled Phase 1 trial show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that supports the potential for durable outcomes.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy and safety of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).

About Cemsidomide in Combination With Elranatamab (ELREXFIO)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide and dexamethasone in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. Data generated from the cemsidomide Phase 1 trial in relapsed/refractory multiple myeloma demonstrate robust T-cell activation and cytokine expression across multiple doses. By activating immune T-cells, cemsidomide, when combined with a BCMAxCD3 bispecific such as elranatamab, may amplify the anti-myeloma immune response and lead to deeper and more durable responses. The study will evaluate different cemsidomide dose levels in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).

About Multiple Myeloma
Multiple myeloma is a blood cancer that affects plasma cells in the bone marrow. It is the second most common blood cancer, with approximately 36,000 people in the United States diagnosed each year. Multiple myeloma is characterized by cycles of remission and relapses, which leads to patients needing multiple lines of therapy to manage this persistent disease. More than 175,000 patients in the United States are estimated to be living with or in remission from myeloma. However, despite treatment advances, approximately 40% of patients do not survive beyond five years.

(Press release, C4 Therapeutics, NOV 5, 2026, View Source [SID1234674299])

On November 5, 2026 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported financial results and corporate updates from the third quarter of 2026.

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John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:

"Our strong third quarter results and raised full-year guidance reflect continued rapid global growth and leadership in hematology, anchored by our foundational BTK inhibitor BRUKINSA, which drives powerful and sustained responses in patients, and now joined by our next-generation BCL2 inhibitor BEQALZI. We look forward to multiple catalysts in the coming months from one of the deepest pipelines in oncology, spanning hematology and solid tumors, accelerated by our differentiated capabilities in R&D, manufacturing, and commercialization."

(Amounts in thousands of U.S. dollars and unaudited)

Three Months Ended Nine Months Ended
September 30, September 30,
2026 2025 % Change 2026 2025 % Change
Net product revenues $ 1,855,057 $ 1,395,013 33 % $ 5,022,180 $ 3,805,619 32 %
Other revenue $ 34,758 $ 17,271 101 % $ 86,144 $ 39,244 120 %
Total revenue $ 1,889,815 $ 1,412,284 34 % $ 5,108,324 $ 3,844,863 33 %
GAAP income from operations $ 418,675 $ 163,114 157 % $ 993,624 $ 262,101 279 %
Adjusted income from operations* $ 612,226 $ 341,184 79 % $ 1,529,649 $ 755,486 102 %
GAAP net income $ 384,706 $ 124,841 208 % $ 849,070 $ 220,431 285 %
Adjusted net income* $ 538,735 $ 303,663 77 % $ 1,358,274 $ 692,622 96 %
GAAP basic EPS per ADS $ 3.38 $ 1.13 199 % $ 7.58 $ 2.03 273 %
Adjusted basic EPS per ADS* $ 4.74 $ 2.76 72 % $ 12.12 $ 6.38 90 %
GAAP diluted EPS per ADS $ 3.28 $ 1.09 201 % $ 7.30 $ 1.96 272 %
Adjusted diluted EPS per ADS* $ 4.59 $ 2.65 73 % $ 11.68 $ 6.14 90 %
Free Cash Flow* $ 473,532 $ 354,469 34 % $ 1,069,423 $ 561,916 90 %

Third Quarter 2026 Financial Results
Product Revenue totaled $1.9 billion for the third quarter of 2026, representing growth of 33% compared to the prior-year period.
•BRUKINSA: Global sales totaled $1.4 billion for the third quarter of 2026, representing growth of 34% compared to the prior-year period; U.S. sales of BRUKINSA totaled $1.0 billion in the third quarter of 2026, representing growth of 36% compared to the prior-year period.
•TEVIMBRA (tislelizumab): Global sales totaled $243 million in the third quarter of 2026, representing growth of 28% compared to the prior-year period.
•Amgen in-licensed products: Global sales totaled $167 million in the third quarter of 2026, representing growth of 26% compared to the prior-year period.
Gross Margin as a percentage of global product sales for the third quarter of 2026 was 88%, compared to 86% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in the Company’s portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA, which was offset by a non-cash intangible asset impairment charge of $22 million associated with our decision to discontinue promotion of POBEVCY. On an adjusted basis, which does not include depreciation and amortization, or the impairment charge, gross margin as a percentage of product sales increased to 90%, from 86% in the comparable period of the prior year.
Operating Expenses
The following table summarizes operating expenses for the third quarter of 2026:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 2026 Q3 2025 % Change Q3 2026 Q3 2025 % Change
Research and development $ 660,784 $ 523,662 26 % $ 586,168 $ 445,904 31 %
Selling, general and administrative $ 593,460 $ 528,998 12 % $ 503,719 $ 434,484 16 %
Total operating expenses $ 1,254,244 $ 1,052,660 19 % $ 1,089,887 $ 880,388 24 %

The following table summarizes operating expenses for the year-to-date period ended September 30, 2026, and 2025:
GAAP Non-GAAP
(unaudited, in thousands, except percentages) Q3 YTD 2026 Q3 YTD 2025 % Change Q3 YTD 2026 Q3 YTD 2025 % Change
Research and development $ 1,814,288 $ 1,530,445 19 % $ 1,586,022 $ 1,311,156 21 %
Selling, general and administrative $ 1,741,771 $ 1,526,199 14 % $ 1,476,386 $ 1,271,650 16 %
Total operating expenses $ 3,556,059 $ 3,056,644 16 % $ 3,062,408 $ 2,582,806 19 %

Research and Development (R&D) Expenses increased for the third quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing early clinical programs into late stage and preclinical programs into the clinic.
Selling, General and Administrative (SG&A) Expenses increased for the third quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth.
Net Income and Basic/Diluted Earnings Per Share
GAAP net income for the third quarter of 2026 was $385 million, an increase of $260 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage. Adjusted net income was $539 million, an increase of $235 million over the prior-year period.

For the third quarter of 2026, basic and diluted earnings per share were $0.26 and $0.25 per share and $3.38 and $3.28 per American Depositary Share (ADS), respectively, compared to $0.09 and $0.08 per share and $1.13 and $1.09 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.36 and $0.35 per share and $4.74 and $4.59 per ADS, respectively, compared to $0.21 and $0.20 per share and $2.76 and $2.65 per ADS in the prior-year period.
Free Cash Flow for the third quarter of 2026 was $474 million, representing an increase of $119 million over the prior-year period.
For further details on BeOne’s Third Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the third quarter of 2026 filed with the U.S. Securities and Exchange Commission.
Full Year 2026 Guidance
BeOne’s financial guidance is summarized below:
Prior FY 2026 Guidance
Current FY 2026 Guidance1
Total revenue $6.6B – $6.8B $6.9B – $7.0B
GAAP gross margin % High-80% range High-80% range
GAAP operating expenses2
(combined R&D and SG&A)
$4.8B – $5.0B $4.9B – $5.0B
GAAP operating income2
$1.0B – $1.1B $1.2B – $1.3B
Non-GAAP operating income2,3
$1.7B – $1.8B $1.9B – $2.0B

1 Assumes November 1, 2026 foreign exchange rates.
2 Does not assume any potential new, material business development activity or unusual/non-recurring items.
3 Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth.
BeOne’s total revenue guidance for full year 2026 of $6.9 billion to $7.0 billion reflects performance through the third quarter and the Company’s expectations for the remainder of the year. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth.
The Company is providing the following additional guidance on items impacting net income and earnings per ADS:
•Other income (expense): Estimated range of $25 million to $50 million in expense, includes interest amortization from the Royalty Pharma arrangement.
•Income tax outlook: Earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized. The Company continues to evaluate and assess the magnitude but expects the reversal will occur in the fourth quarter of 2026. See Form 10-Q for additional updates.
•Diluted ADS outstanding: The Company expects diluted ADSs outstanding of approximately 118 million.
Third Quarter 2026 Business Highlights
Core Marketed Products
BRUKINSA (zanubrutinib)
•Received U.S. Food and Drug Administration (FDA) Priority Review designation for the Phase 3 MANGROVE filing.
•Completed Phase 3 MANGROVE regulatory submissions in the EU and China.
•29 abstracts accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2026 Annual Meeting, including interim analysis results from the Phase 3 MANGROVE study in first-line mantle cell lymphoma (MCL) to be presented during the Plenary Scientific Session.

BEQALZI (sonrotoclax)
•10 abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2026.
TEVIMBRA (tislelizumab)
•Received Japan regulatory approval for the treatment of adult patients with first-line nasopharyngeal cancer.

ZIIHERA (zanidatamab) for which BeOne holds commercialization rights in select markets
•Presented Phase 3 survival data reinforcing benefit of ZIIHERA-containing regimens in first-line HER2+ gastroesophageal adenocarcinoma (GEA) at the European Society for Medical Oncology Congress 2026 (ESMO 2026).
•Received U.S. Food and Drug Administration (FDA) approval for TEVIMBRA-based regimen for first-line HER2+ GEA.

Select Clinical-Stage Programs
Hematology
•6 Tacabrutideg abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2026.
•Tacabrutideg (BTK CDAC): Pivotal Phase 2 portion of CaDAnCe-101 met its primary endpoint of overall response rate in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
•BG-75202 (KAT6 A/B inhibitor): First patient enrolled into monotherapy cohort for the Phase 1 study for the treatment of adult patients with acute myeloid leukemia.
Gastrointestinal Cancers
•BGB-B2033 (GPC3x4-1BB bispecific antibody):
◦Updated data presented at ESMO (Free ESMO Whitepaper) 2026.
◦Received Orphan Drug Designation from the European Commission and awarded Innovation Passport, enabling entry to the UK’s Innovative Licensing and Access Pathway, in hepatocellular carcinoma (HCC).
•BG-85738 (RAS ONi): First patient enrolled in the Phase 1 study of advanced solid tumors with RAS mutations.
Lung Cancer
•BG-C477 (CEA ADC):
◦Disclosed first clinical data at ESMO (Free ESMO Whitepaper) 2026.
◦Received FDA Fast Track Designation for the treatment of patients with advanced or metastatic CEA-high non-small cell lung cancer whose disease has progressed following prior systemic therapy.
•BGB 58067 (MTA-cooperative PRMT5 inhibitor): Disclosed first clinical data at ESMO (Free ESMO Whitepaper) 2026.

Breast and Gynecological Cancers
•BG-C9074 (B7-H4 ADC): Initiated Starstone-301 Phase 3 study in combination with bevacizumab for the treatment of adult patients with first-line ovarian cancer in maintenance setting.

Anticipated R&D Milestones
Programs
Milestones
Timing
BRUKINSA
•Regulatory submission in Japan for the treatment of adult patients with first-line MCL.
Q4 2026
TEVIMBRA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy.
1H 2027
ZIIHERA
•China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA.
1H 2027
Tacabrutideg(BGB-16673)
•Phase 2 potential submission for the treatment of adult patients with R/R CLL.
Mid 2027
•CaDAnCe-306: Phase 3 study initiation for R/R CLL in combination with BEQALZI
1H 2027
BGB-B2033
(GPC3x4-1BB bispecific antibody)
•GroundBBreaker-301 Phase 3 study initiation in second-line or later hepatocellular carcinoma.
Q4 2026
•GroundBBreaker-201 potentially pivotal single-arm Phase 2 study initiation in second-line or later hepatocellular carcinoma.
Q4 2026
•GroundBBreaker-302 pivotal Phase 3 study initiation in first-line hepatocellular carcinoma
1H 2027

Corporate Updates
•Announced a multi-part collaboration with Revolution Medicines, including a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines’ four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets.

•Announced a voluntary agreement with the U.S. Government to expand access to innovative cancer medicines for American patients while strengthening the Company’s U.S manufacturing footprint.
•Announced the renewal of a partnership with the BeOne Care Foundation and The Max Foundation, a leading global health nonprofit organization, to expand access to BRUKINSA for the treatment of adult patients with CLL in low- and middle-income countries through 2028.

BeOne’s Earnings Results Webcast

The Company’s earnings conference call for the third quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Thursday, November 5, 2026, and will be accessible through the Investors section of BeOne’s website at www.beonemedicines.com. Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available.

(Press release, BeOne Medicines, NOV 5, 2026, View Source [SID1234674298])